Image, Body
Conditions
Keywords
MRI hardware testing
Brief summary
Patients and healthy volunteers will be scanned in order to test new sequences.
Detailed description
The aims of this study are to: 1. Conduct clinical protocol development and validation: The settings of an MRI machine are commonly adjusted according to the body part being scanned and the reason for the exam. When testing out new sequences and settings or adjusting existing settings, human subjects (patients and healthy volunteers) may be scanned in order to make sure that the quality of the images produced by the MRI machine is adequate for diagnostic purposes and to obtain normative values. 2. Demonstrate and train: In some cases, human subjects may be scanned for the purposes of demonstrating equipment or for training operators on the safe and effective use of MRI systems.
Interventions
RADIATIONMRI
1.5T or 3T MRI scanner (Siemens Medical Systems)
DRUGGadavist 2Ml Solution for Injection
Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)
Sponsors
Northwestern University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
If a research MRI is combined with a clinically ordered MRI, the research scan will add about 15 minutes to the clinical MRI procedure. If a research MRI is conducted during a separate visit, it is expected that the research-only MRI visit will last about 1-2 hours. An individual may voluntarily participate in the study on multiple occasions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* • At least 18 years of age * Able to complete the MR safety questionnaire. * Able to comprehend and provide informed consent in English. * When contrast is being administered: healthy volunteers with a GFR≥60 ml/min * When contrast is being administered: patients with a GFR ≥30 ml/min
Exclusion criteria
* • When contrast is being administered: subjects with a GFR \< 30 ml/min * When contrast is being administered: subjects with acute kidney injury * When contrast is administered, allergy to gadolinium-containing contrast media * Contraindication to MRI (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions) * Adults unable to consent * Individuals who are not yet adults * Pregnant or breastfeeding women * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conduct clinical protocol development and validation | 5 years | Testing of new MRI pulse sequences will be performed for validation of potential new diagnostic capabilities. The MRI pulse sequences will be routinely performed along with clinically-validated and accepted pulse sequences for comparison of the novel sequences in human subjects (patients and healthy volunteers). Novel sequences will be performed in the accepted method with adjustment of settings to evaluate image qualities and normative values produced by the MRI machine. The resulting images provided by the novel sequences will be able to evaluated for diagnostic quality and to obtain comparison of possible improvements alongside clinically-validated MRI pulse sequences. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate and train | 5 years | Human subjects may be scanned utilizing MRI pulse sequences in the context of a clinical assessment for demonstrating of equipment or sequence function for training of MRI technologist. The sequence will be performed by a skilled technologist with the primary goal of providing information on proper utilizing of MRI hardware and software for technologist who are training and will be possibly utilizing these technique to provided safe and effective use of MRI systems and their software. |
Countries
United States
Outcome results
None listed